I don't think MSB is going to be hit overly hard for walking away from AGVHD, and I won't hold it against them where it's clear the FDA is playing funny buggers and are themselves willing to walk away from this.
Seriously, FDA? You have a 100% safe product and an incredibly sympathetic target group...and you refuse them treatment for YEARS to require a company to spend tens of millions MORE dollars to MAYBE get approval...with no guarantees mind you...
At that point, commercial realities come to the fore. "MSB wanted to help the kids, but the FDA were just being d*cks. We have to run a business, and will be back to AGVHD at some point in the future when it's commercially feasible."
As a shareholder, if I was asked to vote after the FDA puts ALL of the onus on us to continue the trial or not?
I would suggest we shift AGVHD down lower on the "to do" list, instead focusing on those treatments that are more likely to get FDA approval in the near term, i.e., CHF, CLBP, Crohn's, and on other markets that are more receptive to stem cells, i.e., EU, China, Japan.
MSB isn't going to be able to help ANYONE unless it can commercialise products. And that won't happen until it breaks the logjam and overcomes the inherent bias against stem cells the FDA is clearly harbouring.
As a result: Go with treatments that already have an RCT completed or that is about to be completed!
Sorry, kids. MSB is NOT a charity. You have no one to blame but the FDA.
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